FDA 510(k)

EXACTECH GPS

K 號：K152764 · 2016-07-13

決定日期2016-07-13

產品代碼HAW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

EXACTECH GPS is the device name listed in this FDA 510(k) record. The listed applicant is Blue Ortho. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K152764. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EXACTECH GPS?

EXACTECH GPS is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Blue Ortho. The 510(k) number is K152764.

When did EXACTECH GPS receive FDA 510(k) clearance?

EXACTECH GPS received FDA 510(k) clearance on 2016-07-13, under 510(k) number K152764.

Who is the listed applicant for EXACTECH GPS?

The FDA 510(k) record lists Blue Ortho as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXACTECH GPS?

The FDA product code for EXACTECH GPS is HAW.

其他以 Blue Ortho 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：HAW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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